REGISTRATION

REGULATORY AFFAIRS – REIMBURSEMENT

DEVELOPMENT

Martin Biggs Associates is a healthcare / regulatory affairs consultancy with over 30 years experience. We can provide advice and assistance with European, Australian, South African, Chinese and US – FDA authorization of drugs, devices, drug/device combinations, IUDs, and cosmetics.

• Drug / Medicinal Product registration in Europe and other territories
• CE marking / Medical Devices
• FDA Drug and Device registration
• Reimbursement of Drugs / Devices / Borderline Products / Food Supplements
• In vitro Diagnostics registration
• Stategic business planning and acquisitions
• Trademark searches and registration
• Patent and distributor searches
• Patenting – intellectual property management and marketing advice
• EU Cosmetics Directive
• Expert reports
• Advice as to choice of Notified Body and Competent Authority
• Advice on the most cost effective route to CE marking and the choice of Annex
• Selected List Scheme (SLS) and the Pharmaceutical Price Regulation Scheme (PPRS)
• Due diligence studies / risk analysis studies
• Authorized Representative services for Drugs, Devices, and Cosmetics
• Expert witness service
• Strategic marketing / pricing

• Are you having difficulty in obtaining listing of your product in the Drug Tariff?
• Do you need assistance with defending your brands against generic competition?
• Do you need advice on NICE cost-effectiveness reviews?

Consult us on a strictly confidential basis

Others do and have found our services profitable